Synokem gets CDSCO panel nod to study Dyhydogestrone as part of Assisted Reproductive Technology
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to drug major Synokem Pharmaceuticals to conduct the bioequivalence (BE) study and Phase III clinical trial of Dydrogesterone film coated sustained release tablets 20/30mg for the indication of “Luteal support as part of an Assisted Reproductive Technology (ART) treatment”.
However, this recommendation is subject to a condition that that the age group of the study population in Phase III clinical trial should be ≥ 21 and ≤ 42 years of age and are planning to undergo Assisted Reproductive Technology (ART).
This came after the firm presented its proposal for manufacture and marketing permission of Dydrogesterone film coated sustained release tablets 20/30mg for the indication of “Luteal support as part of an Assisted Reproductive Technology (ART) treatment” alongwith Phase III clinical trial protocol and BE protocol respectively as mentioned below, before the committee.
Regarding the Phase III clinical trial protocol, the firm added, "A multicenter, randomized, double-blind, active-controlled, three-arm, parallel-group, Phase III clinical trial to evaluate efficacy and safety of Dydrogesterone SR Tablets 20mg/30mg for Luteal support as part of assisted reproductive technology (ART) treatment."
Furthermore, in connection with the bioequivalence study, the firm state, "An open-label, randomized, balanced, two-treatment, two sequences, two-period, cross-over, single dose, oral bioequivalence study of Dydrogesterone film coated sustained release 30mg tablets (T) manufactured by Synokem Pharmaceuticals Ltd., India with Duphaston (Dydrogesterone tablets IP 10mg (Dose: 3x10mg) (R) manufactured by Abbott India Limited in normal healthy, adult female subjects under fasting condition."
Duphaston 10mg Tablet manufactured by Abbott India treats female infertility, relieves various menstrual problems like heavy unusual menstrual bleeding or pain as well as irregular periods, Premenstrual syndrome (PMS) and endometriosis. It also restores normal menstrual cycles in case periods have stopped before reaching menopause.
Dydrogesterone is a synthetic progesterone for menstrual cycle regulation, infertility treatment, prevention of miscarriage, and other conditions. Dydrogesterone helps to regulate the healthy growth and normal shedding of the uterus lining. Therefore, it may be useful in the treatment of menstrual disorders such as absent, irregular or painful menstrual periods, infertility, premenstrual syndrome and endometriosis.
Dydrogesterone is an orally active progestogen which acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus. At therapeutic levels, dydrogesterone has no contraceptive effect as it does not inhibit or interfere with ovulation or the corpus luteum.
At the recent SEC meeting for Reproductive & Urology held on the 28th of February, the expert panel reviewed the proposal presented by the drug major Synokem Pharmaceuticals for the manufacturing and marketing of the drug Dyhydogestrone film coated sustained release Tablets 20/30mg for Luteal support as part of an Assisted Reproductive Technology (ART) treatment along with Phase III clinical trial protocol and BE protocol.
After detailed deliberation, the committee recommended for grant of permission to conduct the BE study and Phase III clinical trial as per the protocols presented by the firm subject to the condition that the age group of the study population in Phase III clinical trial should be ≥ 21 and ≤ 42 years of age and are planning to undergo ART.
